Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing Amgen’s NEULASTA. ARMLUPEG is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies who are receiving…
On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive FDA approval. Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. POHERDY…
On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. According…
On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first biologic the FDA…
On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products and granted provisional interchangeability designations. BOSAYA™ and AUKELSO™ are RANK ligand inhibitors used to treat…
On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab). SELARSDI is approved for all indications matching the reference product, including for the treatment of moderate to severe plaque psoriasis…
On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. Regeneron reported that the approval is supported by data from FIREFLEYE and BUTTERFLEYE—two phase III clinical trials comparing 0.4…
Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year. RELEUKO references Neupogen®, and is expected to launch in the third quarter of…
July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…
With the support of the economic development organization Invest Puerto Rico, Biosimilar Solutions LLC announced that both it and CytoImmune Therapeutics will be establishing operations on the island to conduct biologics and cell therapy research and development. According to the press release, CytoImmune will relocate to Toa Baja and plans…